The Effect of Same-Day Observed Initiation of Antiretroviral Therapy on HIV Viral Load and Treatment Outcomes in a US Public Health Setting

Abstract

Background: Antiretroviral therapy (ART) is typically begun weeks after HIV diagnosis. We assessed the acceptability, feasibility, safety, and efficacy of initiating ART on the same day as diagnosis.

Methods: We studied a clinic-based cohort consisting of consecutive patients who were referred with new HIV diagnosis between June 2013 and December 2014. A subset of patients with acute or recent infection (<6 months) or CD4 <200 were managed according to a "RAPID" care initiation protocol. An intensive, same-day appointment included social needs assessment; medical provider evaluation; and a first ART dose offered after laboratories were drawn. Patient acceptance of ART, drug toxicities, drug resistance, and time to viral suppression outcomes were compared between RAPID participants and contemporaneous patients (who were not offered the program), and with an historical cohort.

Results: Among 86 patients, 39 were eligible and managed on the RAPID protocol. Thirty-seven (94.9%) of 39 in RAPID began ART within 24 hours. Minor toxicity with the initial regimen occurred in 2 (5.1%) of intervention patients versus none in the nonintervention group. Loss to follow-up was similar in intervention (10.3%) and nonintervention patients (14.9%) during the study. Time to virologic suppression (<200 copies HIV RNA/mL) was significantly faster (median 1.8 months) among intervention-managed patients when compared with patients treated in the same clinic under prior recommendations for universal ART (4.3 months; P = 0.0001).

Conclusions: Treatment for HIV infection can be started on the day of diagnosis without impacting the safety or acceptability of ART. Same-day ART may shorten the time to virologic suppression.

Figure 1. Standard of care and RAPID program models for initiation of outpatient antiretroviral therapy

In the RAPID model, a time-intensive “RAPID” visit was performed as soon as possible following a new diagnosis of HIV. ART was initiated by a RAPID program provider so that the first encounter with the assigned primary provider involved ART management. In the standard model ART was initiated by the primary provider after preparatory visits involving clinic intake, social, psychological, medical and laboratory evaluation.

Figure 2. Uptake of ART when offered immediately after diagnosis

Data shown are for patients with a new HIV diagnosis and attending their first visit to the SFGH HIV Ciinic between 2013 and 2015 during the RAPID intervention program period. The percentage of patients choosing to take ART when offered by RAPID is shown by the black bars: ninety-five percent (37/39) patients elected to begin ART within a day of its being offered. Slower uptake among non-RAPID patients is related to the deferral of the offer to start ART.

Figure 3. Time to viral suppression among patients newly diagnosed with HIV infection, by ART initiation strategy

This Kaplan-Meier plot shows the proportion of patients with viral load <200 copies/mL HIV RNA over time, following referral to the SFGH HIV clinic with a new diagnosis of HIV infection. Time to suppression for patients receiving the RAPID intervention in 2013–2015 (median 1.8 months) was significantly shorter than for patients treated under universal ART guidelines in the immediate pre-RAPID 2010–2013 period (4.3 months, p<.0001) and in the previous CD4 guided 2006–2009 period (7.2 months, p<.0001) represented by dotted line.